Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Syndrome

Carcinoma

Low Anterior Resection Syndrome

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Rectal Diseases

Postoperative Complications

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Loperamide

Antidiarrheals

Coal Tar

Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Dietary Fiber

Enema Administration

Loperamide Hydrochloride

Physical Therapy

Questionnaire Administration

X-Ray Imaging

The Ohio State Comprehensive Cancer Center

Alessandra C. Gasior, DO

Alessandra C Gasior, DO

This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.

PRIMARY OBJECTIVE:

I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.

SECONDARY OBJECTIVE:

I. The determination of feasibility to complete this treatment pathway.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Diarrhea

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Signs and Symptoms, Digestive

Antineoplastic Agents

Herbal and Botanical

Octreotide

Antineoplastic Agents, Hormonal

Cola

loperamide hydrochloride

octreotide acetate

Scott Wadler, MD

Mace L. Rothenberg, MD, FACP

Bhoomi Mehrotra, MD

RATIONALE: Drugs such as octreotide and loperamide hydrochloride use different ways to relieve the diarrhea caused by chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of octreotide with loperamide hydrochloride for the treatment of chemotherapy-related diarrhea in patients who have colorectal cancer.

OBJECTIVES: I. Determine the safety and efficacy of octreotide acetate versus conventional therapy with loperamide hydrochloride for chemotherapy related diarrhea in patients with advanced colorectal malignancies undergoing chemotherapy with fluorouracil or fluorouracil based regimens.

OUTLINE: This is a prospective, randomized, parallel, open label, multicenter study. Patients are stratified by therapy, grade of diarrhea, and prior use of loperamide hydrochloride or octreotide acetate. Patients undergo 1 of 3 treatments. Patients receive either low doses of octreotide (arm A) or high doses of octreotide (arm B) subcutaneously 3 times daily for 5 days. Patients in arm C receive oral doses of loperamide following each unformed stool for 5 days. A diary is completed by patients to record medications and bowel history. Treatment continues if diarrhea persists beyond day 5, but will be considered a treatment failure. If diarrhea continues to worsen, patients are removed from study. All patients are followed for 24 days.

PROJECTED ACCRUAL: This study will accrue a total of 500 patients.

Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer

Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients With Colorectal Cancer

National Cancer Institute (NCI)

SWOG Cancer Research Network

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	NCT06424522	Low Anterior Re... Rectal Carcinom...	Dietary Fiber Enema Administr... Loperamide Hydr... Physical Therap... Questionnaire A... X-Ray Imaging	18 Years -	Ohio State University Comprehensive Cancer Center
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer	NCT00003057	Colorectal Canc... Diarrhea	loperamide hydr... octreotide acet...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer	NCT00003057	Colorectal Canc... Diarrhea	loperamide hydr... octreotide acet...	18 Years - 120 Years	Eastern Cooperative Oncology Group

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